January 30, 2020

Federal Government Responds to Coronavirus Outbreak

On January 28, the CDC expanded screening for the coronavirus (2019-nCoV) to 15 additional U.S. airports. In a press conference back on January 17, the CDC noted that the screening will have the dual purpose of identifying patients who may be ill and educating other travelers so that the disease may be contained. At this time, the CDC has not definitively determined how 2019-nCoV is being spread, particularly when it comes to the period of time before someone begins to show symptoms. While there have been no cases of person-to-person spread of 2019-nCoV in the United States, the CDC has recommended that all nonessential travel to China be avoided as all of the cases in the United States occurred in individuals who had recently travelled from China. 

On January 27, the FDA announced key actions to help develop medical countermeasures (MCMs), such as treatments and diagnostic tests 2019-nCoV. Currently, there are no treatments or commercially-available diagnostic tests for 2019-nCoV, but the FDA is seeking to ease the burden for potential developers of MCMs by sharing updates about the pathways available to expedite the development and availability of such products. The FDA also launched a website with resources for the public, medical professionals, and product developers that describes these efforts.

FDA may be able to accelerate development of MCMs for 2019-nCoV through Emergency Use Authorization (EUA). EUA authority permits the FDA to allow unapproved MCMs to be used during public health emergencies when there are no other “adequate, approved, and available alternatives.” Several EUAs are already in effect for other public health emergencies, including treatment and testing mechanisms for anthrax, Ebola, and Zika. Drug and diagnostic test developers are encouraged to reach out to the FDA for more information.